Description
As Associate Medical Director, Safety Evaluation and Risk Management (SERM), you will provide medical/scientific expertise in the safety evaluation and risk management of GSK assets in clinical development and/or the post-marketing setting.
You will contribute to clinical safety and pharmacovigilance strategy for assets within Global Safety, collaborating with senior governance and partner teams to drive evidence-based safety decisions.
Key Responsibilities:
- Provide medical leadership across clinical programs, contribute to clinical trial design, safety oversight, and scientific communication.
- Work closely with cross-functional teams including Clinical Operations, Safety, Regulatory, Biostatistics, and Commercial.
- Ensure scientifically sound review and interpretation of data and management of safety issues.
- Escalate safety issues identified through the safety review process to senior management and safety governance as appropriate.
Basic Qualification:
- Medical degree, with completion of a formal postgraduate clinical training, residency or specialty training.
- Experience in the pharmaceutical or biotechnology industry working in pharmacovigilance or drug safety.
- Experience in clinical safety and pharmacovigilance activities, including evidence generation, benefit–risk assessment, causality assessment and evaluation of safety signals.
Preferred Qualification:
- Proven record of high-quality, timely decision-making and creative problem-solving in complex or critical safety situations.
- Experience leading or contributing to safety governance activities, such as safety advisory panels and senior governance committees.
- Experience with successful global regulatory filings.
Working arrangement:
- This role is hybrid, with flexibility to work on-site 2 to 3 days per week.